Class II

Medical Device Recall: Cardinal Health Presource Kits: 1 ) KIT, MAJOR ORAL SURGERY, Catalog Number: PGDHMOWOE; 2 ) ORP DENTAL PACK , Catalog Number: SENHDDPVCH; 3 ) ORP DENTAL PACK, Catalog Number: SENHDDPVCI

Cardinal Health 200, LLC · November 8, 2024

Reason for Recall

Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.

States Affected

NATIONWIDE

Quantity Affected

512,786 total units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0911-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.